Determine Return on Investment in Heart Failure Remote Monitoring Program
A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program
1 other identifier
interventional
163
1 country
1
Brief Summary
The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 31, 2016
March 1, 2016
2 years
June 12, 2015
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
31 days post discharge with a heart failure-related hospital re-hospitalization.
31 days
Secondary Outcomes (6)
Communication with healthcare provider or emergency department
31 days
Number of non-conformity issues
31 days
Health-related quality of life Questionnaire
31 days
Subject satisfaction Questionnaire
31 days
Physician satisfaction Questionnaire
31 days
- +1 more secondary outcomes
Other Outcomes (2)
Number and type of incidents
31 days
Subject attrition
31 days
Study Arms (3)
Control
EXPERIMENTALControl: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.
Intervention 1
EXPERIMENTALIntervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
Intervention 2
EXPERIMENTALIntervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program.
Interventions
home remote monitoring
Eligibility Criteria
You may qualify if:
- Absence of significant vision, hearing, or other communication deficits
- English speaking;
- Capable and willing to give informed consent;
- Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
- Living in a private home;
- Hospital admission for Heart Failure or decompensation in the previous 12 months
- New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
- Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
- Left ventricular ejection fraction \<40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
- NYHA class II-III who had an ejection fraction \>40% and evidence of diastolic left ventricular dysfunction.
- Optional subject with a diagnosis of diabetes (indicated by HbA1c \>7).
You may not qualify if:
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
- Females who are pregnant, planning to become pregnant within 3 months, or lactating;
- Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
- Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
- End-stage heart failure requiring regular inotropic drug infusions;
- Chronic renal failure requiring dialysis treatment and
- Unstable angina.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NCH Healthcare System
Naples, Florida, 34102, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Morrison, PhD
NCH Healthcare System Inc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 18, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
March 31, 2016
Record last verified: 2016-03